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IRCT20200409047007N3 IRCT 2021-12-02 Mashhad University of Medical Sciences The effect of concurrent administration of melatonin and neoadjuvant Chemotherapy on the pathological response in breast cancer patients The effect of concurrent administration of melatonin and neoadjuvant Chemotherapy on the pathological response in breast cancer patients 2021-12-06 anticipated 52 Complete https://irct.ir/trial/59341 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients are randomly placed in blocks of 6. In each block, 3 patients receive melatonin and 3 patients receive placebo and patients are placed in blocks in the order of enrollment, Blinding description: Randomization was performed by Dr. Fazelipour and only she knows the type of medicine that is prescribed to each patient. The coded drug packages will be placed in the pharmacy next to the chemotherapy ward and will be delivered to each patient according to the code given to him. Patients, planners, physicians, and those who analyze the data are unaware of the type of medication each patient is receiving. 3 Breast Cancer. Intervention 1: Intervention group: Patients are prescribed a 10 mg tablet of melatonin at bedtime during a 5-month course of chemotherapy. Intervention 2: Control group: Patients in the control group are given one placebo tablet (similar to melatonin tablets) each night during a 5-month course of chemotherapy. Yes - There is a plan to make this available What will be shared: After collecting and analyzing the data, the results will be made available to the public in the form of articles. When: After the publication of the article To whom: Physicians Conditions: There are no restrictions Where to obtain: Dr Mohsen Seddigh Shamsi, Mashhad University of Medical Science How to obtain: Refer to the project supervisor Comments:
public Dr Mohsen Seddigh Shamsi
Department of Internal Medicine, Imam Reza Hospital, Shariati Square
Mashhad Iran (Islamic Republic of) ٩١٣٧٩١٣٣١۶ +98 51 3859 8818 seddighshamsim@mums.ac.ir Mashhad University of Medical Sciences scientific Dr Mohsen Seddigh-Shamsi
Department of Internal Medicine, Imam Reza Hospital, Shariati Square
Mashhad Iran (Islamic Republic of) ٩١٣٧٩١٣٣١۶ 009851385988188 seddighshamsim@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Patients with stage one to three breast cancers Age 30 to 60 years at the time of starting chemotherapy 30 years 60 years Female No previous history of chemotherapy Absence of contraindications to neoadjuvant chemotherapy for breast cancer including heart failure and drug sensitivity Absence of uncontrolled diabetes, renal failure with glomerular filtration less than 30 and liver failure C50.9 Malignant neoplasm: Breast, unspecified Treatment - Drugs Placebo Intervention group: Patients are prescribed a 10 mg tablet of melatonin at bedtime during a 5-month course of chemotherapy. Control group: Patients in the control group are given one placebo tablet (similar to melatonin tablets) each night during a 5-month course of chemotherapy. Pathological response. Timepoint: surgery after neoadjuvant chemotherapy. Method of measurement: The pathological response after neoadjuvant chemotherapy is assessed according to the Chevallier system as follows:1- Pathological complete response: Disappearance of all the tumor cells in breast and lymph nodes2- Pathological partial response: Presence of invasive carcinoma with stromal alterations3- Pathological no response: little modification in the original tumor appearance. Quality of life. Timepoint: At beginning and end of chemotherapy. Method of measurement: EORTC QLQ – BR23 questionnaire. Mashhad University of Medical Sciences Approved 2021-08-01 Ethics Committee of Mashhad University of Medical Sciences Central University Building, University Street, Mashhad, Iran Mashhad Razavi Khorasan Iran (Islamic Republic of)